RMI INTERNAL MAMMARY ARTERY CANNULA

K960098 · Research Medical, Inc. · DQR · Mar 26, 1996 · Cardiovascular

Device Facts

• Record ID: K960098
• Device Name: RMI INTERNAL MAMMARY ARTERY CANNULA
• Applicant: Research Medical, Inc.
• Product Code: DQR · Cardiovascular
• Decision Date: Mar 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1300
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

RMI Internal Mammary Artery Cannula used for flushing internal mammary artery with vasodilator. Device consists of chrome-plated brass female luer hub and 304 stainless steel tubing with 1mm smooth bulb tip. Operated by clinicians during surgical procedures. Device facilitates delivery of vasodilator to artery; higher flow rate compared to predicate ensures adequate flushing without excessive pressure requirements. Benefits patient by enabling effective arterial preparation during surgery.

Clinical Evidence

Bench testing only. Comparative performance test measured relative flow rates between RMI IMA-001 and DLP I.M.A. 31001. RMI device demonstrated approximately 25% greater flow rate than predicate.

Technological Characteristics

Materials: Chrome-plated brass female luer hub, 304 stainless steel tubing. Tip: 1mm smooth bulb. Dimensions: 26 gauge tubing. Sterilization: Ethylene Oxide (EtO).

Indications for Use

Indicated for flushing the internal mammary artery with a vasodilator.

Regulatory Classification

Identification

A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

Predicate Devices

• DLP I.M.A. Cannula (Code #31001)

Submission Summary (Full Text)

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K960098

MAR 26 1996

# Attachment II.A.

# SMDA Summary of Safety and Effectiveness Information

In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:

1. Predicate Device Identification: A claim of substantial equivalence of the RMI Internal Mammary Artery Cannula is made to the:

- DLP I.M.A. Cannula, Code #31001, K# Unknown.

This device was marketed prior to May 28, 1976 or has received FDA clearance to market since that date.

2. Class III Summary:

[Not applicable]

3. Statement of Biocompatibility:

The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip. These materials are standard materials used in medical needle devices marketed prior to May 28, 1976, and since that date. Biocompatibility of these materials is well established and testing is not repeated for this product.

4. Comparative Information:

- Summary of Functionality/Performance Comparison of the RMI Internal Mammary Artery Cannula to the DLP I.M.A. Cannula:

# Test Results

A comparative performance test of the RMI Internal Mammary Artery Cannula, IMA-001, to the DLP I.M.A. Cannula, I.M.A. 31001, was completed. The purpose of the test was to compare the relative flow rates of the cannulae. Under conditions of the test the data shows that the flowrate of the RMI Internal Mammary Artery Cannula, IMA-001, is approximately 25% greater than the DLP I.M.A. Cannula, I.M.A. 31001. Since the flowrate through a cannula indicated for flushing the internal mammary artery with a vasodilator is only an issue if the pressure needed to create the desired flow is too high, it may be concluded that in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001.

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Comparison of Specifications

| Characteristic | RMI Internal
Mammary Cannula | DLP I.M.A.
Cannula |
| --- | --- | --- |
| Model | RMI IMA-001 | DLP I.M.A. 31001 |
| Female Luer Hub | Chrome-Plated Brass | Plastic |
| Tubing | 26 gauge Stainless Steel | 26 gauge Stainless Steel |
| Tip | 1mm Smooth Bulb Tip | 1mm Smooth Bulb Tip |
| Sterilization | EtO | Unknown |